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| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
This is a Phase II trial to evaluate the efficacy and safety of human leukocyte antigen (HLA) partially-matched third-party allogeneic Epstein-Barr virus cytotoxic T lymphocytes (EBV-CTLs) for the treatment of EBV-induced lymphomas and EBV-associated malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCT EBV+ PTLD R/R Rituximab | Experimental | Patients with Epstein-Barr virus positive (EBV+) posttransplant lymphoproliferative disorders (PTLD) hematopoietic cell transplant (HCT) who were relapse/refractory (R/R) to rituximab will receive IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
|
| SOT EBV+ PTLD R/R Rituximab | Experimental | Patients with EBV+PTLD solid organ transplant (SOT) who were R/R to rituximab or R/R to rituximab and chemotherapy will receive IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After 3 week observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
|
| EBV+ AID-LPD | Experimental | Patients with EBV+ acquired immunodeficiency (AID) lymphoproliferative disorder (LPD) will receive IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity |
|
| EBV+ PID-LPD | Experimental | Patients with EBV+ primary immunodeficiency (PID) LPD will receive IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBV-specific T cells (EBV-CTLs) | Biological | EBV-CTLs are cytotoxic T lymphocytes that specifically kill cells presenting EBV protein antigens including EBV-transformed B lymphocytes responsible for EBV-associated lymphomas and lymphoproliferative disorders. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The ORR is defined as percentage of participants with best overall response of complete remission/response (CR) or partial remission/response (PR) based on investigator's assessment. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR is complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel; and PR is a 50 % or greater reduction in the size of all lymphomatous lesions as determined by computed tomography (CT) or magnetic resonance imaging (MRI) measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR is clearance of EBV without subsequent development of EBV+ LPD; and PR is at least a 10-fold decrease in EBV DNA levels. | From Day 1 through 65.3 months after Day 1 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The OS is defined as the time from the first dose of tabelecleucel to the date of death due to any cause. The OS was estimated using Kaplan-Meier method. Participants who were lost to follow-up or still alive were censored on the last known-to-be-alive date. | From Day 1 through 65.3 months after Day 1 dose |
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Inclusion Criteria:
OR
OR
Persistent or recurrent elevations in levels of EBV DNA exceeding 500 copies/ml in patients previously treated for EBV-LPD with chemotherapy and/or rituximab who do not yet have clinically or radiologically evaluable disease but are at high risk of disease recurrence.
EBV-specific T cells are available for adoptive immune cell therapy from a consenting third party donor. The third party EBV-CTLs to be administered will be selected on the basis of two criteria: 1) that they are matched for at least 2 HLA antigens and 2) that they are restricted by an allele shared with the EBV+ malignancy (if known), or with the donor in HSCT recipients, or patient in organ transplant or immunodeficient patients
KPS or Lansky score ≥ 20.
A life expectancy of at least 6 weeks.
Adequate bone marrow, heart, lung, liver and kidney function at the time of treatment with EBV-specificT cells is initiated, including:
However, abnormalities of specific organs will not be considered grounds for exclusion if they are the result of the EBV+ malignancy or its treatment (e.g. a renal allograft recipient with an EBV LPD may be on dialysis because the allograft was rejected when the immune suppression was stopped as a first approach to treatment of the EBV LPD). At the discretion of the investigator, patients with elevated but stable creatinine will not be precluded from treatment on study.
There is no age restriction to eligibility for this protocol.
It is expected that five types of patients afflicted with EBV-associated lymphomas, lymphoproliferative diseases or malignancies will be referred and will consent to participate in this trial. These are:
Exclusion Criteria:
The following patients will be excluded from this study:
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| Name | Affiliation | Role |
|---|---|---|
| Minoti Hiremath, MD | Atara Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31689242 | Derived | Prockop S, Doubrovina E, Suser S, Heller G, Barker J, Dahi P, Perales MA, Papadopoulos E, Sauter C, Castro-Malaspina H, Boulad F, Curran KJ, Giralt S, Gyurkocza B, Hsu KC, Jakubowski A, Hanash AM, Kernan NA, Kobos R, Koehne G, Landau H, Ponce D, Spitzer B, Young JW, Behr G, Dunphy M, Haque S, Teruya-Feldstein J, Arcila M, Moung C, Hsu S, Hasan A, O'Reilly RJ. Off-the-shelf EBV-specific T cell immunotherapy for rituximab-refractory EBV-associated lymphoma following transplantation. J Clin Invest. 2020 Feb 3;130(2):733-747. doi: 10.1172/JCI121127. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | HCT EBV+ PTLD R/R Rituximab | Participants with Epstein-Barr virus positive (EBV+) posttransplant lymphoproliferative disorders (PTLD) hematopoietic cell transplant (HCT) who were relapse/refractory (R/R) to rituximab received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2018 | Jun 30, 2022 |
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|
| EBV+ Viremia | Experimental | Patients with EBV+ viremia will receive IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
|
| EBV+ Leiomyosarcoma | Experimental | Patients with EBV+ leiomyosarcoma (LMS) will receive IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
|
| EBV+ Lymphoma | Experimental | Patients with EBV+ lymphoma will receive IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
|
| EBV+ NPC | Experimental | Patients with EBV+ nasopharyngeal carcinoma (NPC) will receive IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
|
| EBV+ Other Solid Tumor | Experimental | Patients with EBV+ other solid tumors will receive IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
|
|
| OS Rate at 12 Months |
Percentage of participants with OS at 12 months are reported. The OS is defined as the time from the first dose of tabelecleucel to the date of death due to any cause. The OS was estimated using Kaplan-Meier method. Participants who were lost to follow-up or still alive were censored on the last known-to-be-alive date. |
| From Day 1 through 12 months after Day 1 dose |
| OS Follow-up Time | The OS follow-up time are reported. The OS is defined as the time from the first dose of tabelecleucel to the date of death due to any cause. The OS was estimated using Kaplan-Meier method. Participants who were lost to follow-up or still alive were censored on the last known-to-be-alive date. | From Day 1 through 65.3 months after Day 1 dose |
| Time to Response (TTR) | The TTR is defined as the time from the date of the first dose of tabelecleucel to the date of a PR or CR, whichever occurred first. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR is defined as complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel; and a PR is defined as a 50 % or greater reduction in the size of all lymphomatous lesions as determined by CT or MRI scan measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR is defined as clearance of EBV without subsequent development of EBV+ LPD; and PR is defined as at least a 10-fold decrease in EBV DNA levels. | From Day 1 through 65.3 months after Day 1 dose |
| FG001 | SOT EBV+ PTLD R/R Rituximab | Participants with EBV+PTLD solid organ transplant (SOT) who were R/R to rituximab or R/R to rituximab and chemotherapy received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After 3 week observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| FG002 | EBV+ AID-LPD | Participants with EBV+ acquired immunodeficiency (AID) lymphoproliferative disorder (LPD) received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Results from participants in this arm are being excluded due to the low single digit numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications in this single center study. |
| FG003 | EBV+ PID-LPD | Participants with EBV+ primary immunodeficiency (PID) LPD received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Results from participants in this arm are being excluded due to the low single digit numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications in this single center study. |
| FG004 | EBV+ Viremia | Participants with EBV+ viremia received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Results from participants in this arm are being excluded due to the low single digit numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications in this single center study. |
| FG005 | EBV+ Leiomyosarcoma | Participants with EBV+ leiomyosarcoma (LMS) received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Results from participants in this arm are being excluded due to the low single digit numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications in this single center study. |
| FG006 | EBV+ Lymphoma | Participants with EBV+ lymphoma received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| FG007 | EBV+ NPC | Participants with EBV+ nasopharyngeal carcinoma (NPC) received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| FG008 | EBV+ Other Solid Tumor | Participants with EBV+ other solid tumors received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Results from participants in this arm are being excluded due to the low single digit numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications in this single center study. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Full analysis set included all participants who received at least one dose of tabelecleucel. Results from arms with <= 3participants (EBV+ AID-LPD, EBV+ PID-LPD, EBV+ Viremia, EBV+ Leiomyosarcoma, and EBV+ Other Solid Tumor) are being excluded due to the low single digit numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications in this single center study.
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| ID | Title | Description |
|---|---|---|
| BG000 | HCT EBV+ PTLD R/R Rituximab | Participants with EBV+ PTLD HCT who were R/R to rituximab received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| BG001 | SOT EBV+ PTLD R/R Rituximab | Participants with EBV+PTLD SOT who were R/R to rituximab or R/R to rituximab and chemotherapy received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After 3 week observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| BG002 | EBV+ Lymphoma | Participants with EBV+ lymphoma received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| BG003 | EBV+ NPC | Participants with EBV+ NPC received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | The ORR is defined as percentage of participants with best overall response of complete remission/response (CR) or partial remission/response (PR) based on investigator's assessment. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR is complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel; and PR is a 50 % or greater reduction in the size of all lymphomatous lesions as determined by computed tomography (CT) or magnetic resonance imaging (MRI) measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR is clearance of EBV without subsequent development of EBV+ LPD; and PR is at least a 10-fold decrease in EBV DNA levels. | Full analysis set included all participants who received at least one dose of tabelecleucel. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 through 65.3 months after Day 1 dose |
|
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| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The OS is defined as the time from the first dose of tabelecleucel to the date of death due to any cause. The OS was estimated using Kaplan-Meier method. Participants who were lost to follow-up or still alive were censored on the last known-to-be-alive date. | Full analysis set included all participants who received at least one dose of tabelecleucel. Participants who were lost to follow-up or still alive were censored on the last known-to-be-alive date. | Posted | Median | 95% Confidence Interval | Months | From Day 1 through 65.3 months after Day 1 dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | OS Rate at 12 Months | Percentage of participants with OS at 12 months are reported. The OS is defined as the time from the first dose of tabelecleucel to the date of death due to any cause. The OS was estimated using Kaplan-Meier method. Participants who were lost to follow-up or still alive were censored on the last known-to-be-alive date. | Full analysis set included all participants who received at least one dose of tabelecleucel. Participants who were lost to follow-up or still alive were censored on the last known-to-be-alive date. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 through 12 months after Day 1 dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | OS Follow-up Time | The OS follow-up time are reported. The OS is defined as the time from the first dose of tabelecleucel to the date of death due to any cause. The OS was estimated using Kaplan-Meier method. Participants who were lost to follow-up or still alive were censored on the last known-to-be-alive date. | Full analysis set included all participants who received at least one dose of tabelecleucel. | Posted | Median | Full Range | Months | From Day 1 through 65.3 months after Day 1 dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | The TTR is defined as the time from the date of the first dose of tabelecleucel to the date of a PR or CR, whichever occurred first. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR is defined as complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel; and a PR is defined as a 50 % or greater reduction in the size of all lymphomatous lesions as determined by CT or MRI scan measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR is defined as clearance of EBV without subsequent development of EBV+ LPD; and PR is defined as at least a 10-fold decrease in EBV DNA levels. | Full analysis set included all participants who received at least one dose of tabelecleucel. Participants who achieved CR or PR were analyzed for this outcome measure. | Posted | Median | Full Range | Months | From Day 1 through 65.3 months after Day 1 dose |
|
From Day 1 through 65.3 months after Day 1 dose
Combined AE data for all enrolled participants are reported because few arms had <=3 participants which poses a risk of participant identification with rare indications in this study. Treatment-emergent SAEs includes events collected retrospectively and prospectively per protocol. Non-serious AEs were not collected, hence reported as '0'. In participant flow, 'Deaths' are reported as a reason for study discontinuation, whereas in 'All-Cause Mortality' deaths due to any cause are reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Total | All eligible participants with EBV+ received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. | 46 | 87 | 46 | 87 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pericarditis constrictive | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Diabetes insipidus | Endocrine disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hepatobiliary disease | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Periorbital infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Second primary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
Not provided
In this investigator-led study, scans were only collected as clinically indicated in lieu of a defined schedule; therefore, disease assessment endpoints (duration of response, durable response rate, progression-free survival, time to progression) may not be reliable, hence not reported. Study 11-130 was designed for patient treatment and conducted mostly as investigator-sponsored, single-center until Atara assumed responsibility, then relevant data was transferred from the investigator to Atara.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Atara Biotherapeutics | 650-278-8930 | 1 | clinicalstudies@atarabio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 2, 2019 | Jun 30, 2022 | SAP_001.pdf |
| >=18 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| EBV+ Lymphoma |
Participants with EBV+ lymphoma received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| OG003 | EBV+ NPC | Participants with EBV+ NPC received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
|
|
| OG002 | EBV+ Lymphoma | Participants with EBV+ lymphoma received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| OG003 | EBV+ NPC | Participants with EBV+ NPC received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
|
|
Participants with EBV+ lymphoma received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| OG003 | EBV+ NPC | Participants with EBV+ NPC received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
|
|
| SOT EBV+ PTLD R/R Rituximab |
Participants with EBV+PTLD SOT who were R/R to rituximab or R/R to rituximab and chemotherapy received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After 3 week observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| OG002 | EBV+ Lymphoma | Participants with EBV+ lymphoma received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
| OG003 | EBV+ NPC | Participants with EBV+ NPC received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. |
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